BIRMINGHAM, AL – Effective Jan. 1, 2019, Blue Cross Blue Shield of Alabama will no longer cover OxyContin for members with the exception of Blue Advantage members. This is in response to concerns for members’ care and safety.

Since 2015, opioid prescriptions in the U.S. and in Alabama have declined. Over the last two years, opioid prescriptions for BCBS Alabama’s commercial members have decreased 18 percent. While progress is being made, this issue calls for continued action by all parties.

Beginning Jan. 1, 2019, the following changes to Blue Cross’ Opioid Management Strategy for commercial members will be implemented:

Roxybond, the new instant release oxycodone formulation that is considered “abuse deterrent” by the FDA, will be covered.

Lucemyra (lofexidine), the first non-opioid approved drug to treat the symptoms of opioid withdrawal, will be covered.

OxyContin, and its generic (oxycodone ER), will no longer be covered. Xtampza ER (oxycodone ER) will be available to all members at a non-preferred brand cost share.

Letters have been mailed to members receiving OxyContin or oxycodone ER notifying them of the change and recommending that they follow up with their doctor to discuss potential alternatives. Providers have also been notified with a list of covered alternatives.

Several alternatives will be covered at the lowest copay for members who need a long-acting opioid for around the clock pain management: Morphine ER, Tramadol ER, Fentanyl ER and Methadone will be covered.

Blue Cross always encourages its members to consult their doctors about any treatments or prescription drugs they may need, and the company relies on physicians’ expertise to know what is best for their patients. Blue Cross will continue to develop and adopt actionable policies and procedures that promote safe prescribing of opioid medication and appropriate access to treatment for opioid use disorder. In addition, we will continue to collaborate with Alabama physicians and pharmacists to help curb the growing epidemic of opioid misuse by offering support, resources, and educational tools to network providers. This, combined with our strategies to improve access to medications used to treat substance abuse and drug overdoses, demonstrate our commitment to the health of our membership.

The number of people hospitalized because of amphetamine use is skyrocketing in the United States, but the resurgence of the drug largely has been overshadowed by the nation’s intense focus on opioids.

Amphetamine-related hospitalizations jumped by about 245 percent from 2008 to 2015, according to a recent study in the Journal of the American Medical Association. That dwarfs the rise in hospitalizations from other drugs, such as opioids, which were up by about 46 percent. The most significant increases were in Western states.

The surge in hospitalizations and deaths due to amphetamines “is just totally off the radar,” said Jane Maxwell, an addiction researcher. “Nobody is paying attention.”

Doctors see evidence of the drug’s comeback in emergency departments, where patients arrive agitated, paranoid and aggressive. Paramedics and police officers see it on the streets, where suspects’ heart rates are so high that they need to be taken to the hospital for medical clearance before being booked into jail. And medical examiners see it in the morgue, where in a few states, such as Texas and Colorado, overdoses from meth have surpassed those from the opioid heroin.

Amphetamines are stimulant drugs, which are both legally prescribed to treat attention deficit hyperactivity disorder and produced illegally into methamphetamine. Most of the hospitalizations in the study are believed to be due to methamphetamine use.

Commonly known as crystal meth, methamphetamine was popular in the 1990s before laws made it more difficult to access the pseudoephedrine, a common cold medicine, needed to produce it. In recent years, law enforcement officials said, there are fewer domestic meth labs and more meth is smuggled in from south of the border.

As opioids become harder to get, police said, more people have turned to meth, which is inexpensive and readily available.

Lupita Ruiz, 25, started using methamphetamine in her late teens but said she has been clean for about two years. When she was using, she said, her heart beat fast, she would stay up all night and she would forget to eat.

Ruiz, who lives in Spokane, Wash., said she was taken to the hospital twice after having mental breakdowns related to methamphetamine use, including a monthlong stay in the psychiatric ward in 2016. One time, Ruiz said, she yelled at and kicked police officers after they responded to a call to her apartment. Another time, she started walking on the freeway but doesn’t remember why.

“It just made me go crazy,” she said. “I was all messed up in my head.”

The federal government estimates that more than 10,000 people died of meth-related drug overdoses last year. Deaths from meth overdose generally result from multiple organ failure or heart attacks and strokes, caused by extraordinary pulse rates and skyrocketing blood pressure.

In California, the number of amphetamine-related overdose deaths rose by 127 percent from 456 in 2008 to 1,036 in 2013. At the same time, the number of opioid-related overdose deaths rose by 8.4 percent from 1,784 to 1,934, according to the most recent data from the state Department of Public Health.

“It taxes your first responders, your emergency rooms, your coroners,” said Robert Pennal, a retired supervisor with the California Department of Justice. “It’s an incredible burden on the health system.”

Costs also are rising. The JAMA study, based on hospital discharge data, found that the cost of amphetamine-related hospitalizations had jumped from $436 million in 2003 to nearly $2.2 billion by 2015. Medicaid was the primary payer.

“There is not a day that goes by that I don’t see someone acutely intoxicated on methamphetamine,” said Dr. Tarak Trivedi, an emergency room physician in Los Angeles and Santa Clara counties. “It’s a huge problem, and it is 100 percent spilling over into the emergency room.”

Trivedi said many psychiatric patients are also meth users. Some act so dangerously that they require sedation or restraints. He also sees people who have been using the drug for a long time and are dealing with the downstream consequences.

In the short term, the drug can cause a rapid heart rate and dangerously high blood pressure. In the long term, it can cause anxiety, dental problems and weight loss.

“You see people as young as their 30s with congestive heart failure as if they were in their 70s,” he said.

Jon Lopey, the sheriff-coroner of Siskiyou County in rural Northern California, said his officers frequently encounter meth users who are prone to violence and in the midst of what appear to be psychotic episodes. Many are emaciated and have missing teeth, dilated pupils and a tendency to pick at their skin because of a sensation of something beneath it.

“Meth is very, very destructive,” said Lopey, who also sits on the executive board of the California Peace Officers Association. “It is just so debilitating the way it ruins lives and health.”

Nationwide, amphetamine-related hospitalizations were primarily due to mental health or cardiovascular complications of the drug use, the JAMA study found. About half of the amphetamine hospitalizations also involved at least one other drug.

Because there has been so much attention on opioids, “we have not been properly keeping tabs on other substance use trends as robustly as we should,” said study author Dr. Tyler Winkelman, a physician at Hennepin Healthcare in Minneapolis.

Sometimes doctors have trouble distinguishing symptoms of methamphetamine intoxication and underlying mental health conditions, said Dr. Erik Anderson, an emergency room physician at Highland Hospital in Oakland, Calif. Patients also may be homeless and using other drugs alongside the methamphetamine.

Unlike opioid addiction, meth addiction cannot be treated with medication. Rather, people addicted to the drug rely on counseling through outpatient and residential treatment centers.

The opioid epidemic, which resulted in about 49,000 overdose deaths last year, recently prompted bipartisan federal legislation to improve access to recovery, expand coverage to treatment and combat drugs coming across the border.

There hasn’t been a similar recent legislative focus on methamphetamine or other drugs. And there simply aren’t enough resources devoted to amphetamine addiction to reduce the hospitalizations and deaths, said Maxwell, a researcher at the Addiction Research Institute at the University of Texas at Austin. The number of residential treatment facilities, for example, has continued to decline, she said.

“We have really undercut treatment for methamphetamine,” Maxwell said. “Meth has been completely overshadowed by opioids.”

Despite years of warnings that older adults shouldn’t take sedative drugs that put them at risk of injury and death, a new study reveals how many primary care doctors are still prescribing them, how often, and where the practice is most prevalent.

Mapped out county by county, the nationwide study shows wide variation in prescriptions of the drugs known as benzodiazepines. Some counties, especially in the Deep South and rural western states, had three times the level of sedative prescribing as those with the lowest levels.

Researchers found that top prescribers of drugs such as Xanax, Ativan and Valium also tended to be high-intensity prescribers of opioid painkillers.

The counties with the most intense sedative prescribing tended to have lower incomes, less-educated populations, and higher suicide rates, the study finds. They also overlap with other maps showing high county-level opioid painkiller prescribing.

“Taken all together, our findings suggest that primary care providers may be prescribing benzodiazepines to medicate distress,” says Donovan Maust, M.D., M.Sc., a geriatric psychiatrist from the University of Michigan who led the study with a team from U-M and the University of Pennsylvania.

“And since these drugs increase major health risks, especially when taken with opioid painkillers, it’s quite possible that benzodiazepine prescribing may contribute to the shortened life expectancies that others have observed in residents of these areas.”

Where prescriptions are highest

The study is based on data about all prescriptions written in 2015 by primary care providers for patients in the Medicare Part D prescription drug program. The researchers combined that information with county-level health and socioeconomic data from the County Health Rankings project, a project of the Robert Wood Johnson Foundation and University of Wisconsin.

In the single year studied, the 122,054 primary care providers included in the study prescribed 728 million days’ worth of benzodiazepines to their patients, at a cost of $200 million.

The states with the highest intensity of prescribing — which the researchers defined as prescription days of benzodiazepines relative to all prescribed medication days — were Alabama, Tennessee, West Virginia, Florida and Louisiana.

States with the lowest intensity were Minnesota, Alaska, New York, Hawaii and South Dakota.

Across all types of providers, primary care and otherwise, benzodiazepines accounted for 2.3 percent of all medication days prescribed to Part D participants by those providers that year.

Primary care doctors accounted for 62 percent of all benzodiazepine prescriptions. This confirms other findings that led Maust and his colleagues to focus on primary care providers in the new study. Previous studies have shown such providers account for the majority of benzodiazepines prescribed to older adults, a population much less likely than younger adults to see a psychiatrist.

Higher sedative prescription intensity was also associated at the county level with more days of poor mental health, a higher proportion of disability-eligible Medicare beneficiaries, and a higher suicide rate.

More about sedative risks

Benzodiazepines have often been prescribed to ease anxiety or insomnia, though several studies by Maust and others have shown that patients receiving the drugs often don’t have a formal diagnosis of either condition.

More about the study

To be included in the county-level study, a given primary care provider had to prescribe a benzodiazepine at least 10 times in 2015. The individual physician-level study looked at 109,700 doctors after excluding the 10 percent of prescribers who saw the fewest Medicare beneficiaries.

The researchers divided individual prescribers into four groups according to the intensity level of their benzodiazepine prescribing.

The range was large. For the lowest group, about 0.6 percent of total prescriptions were for benzodiazepines, compared with 3.9 percent for the highest-intensity group. That’s a 6.5-fold difference in benzodiazepine prescribing.

Those in the highest-intensity group were also likely to be high-intensity prescribers for opioids and antibiotics, and also for other drugs that have been classed as high-risk for older adults.

“That the same providers appear to be high-intensity prescribers of both medications is potential cause for concern,” says Maust.

Female primary care providers were less likely to be high-intensity benzodiazepine prescribers. The more years a physician had been in practice, the higher their chance of being a high-intensity prescriber.

Physicians with higher percentages of patients who were white or who received Extra Help payments available to low-income, low-resource patients under Part D of Medicare were also more likely to be high-intensity sedative prescribers.

Researchers could not see data down to the patient-level in the available Medicare data, so they couldn’t look at what conditions patients were listed as having, other clinical findings, or the patients’ individual social and economic status.

BOSTON — According to a new NPR/Robert Wood Johnson Foundation/Harvard T.H. Chan School of Public Health poll, rural Americans cite drug/opioid abuse as the biggest problem facing their local community (25 percent), followed by economic concerns (21 percent).

The poll of 1,300 adults living in the rural United States found that a majority of rural Americans (57 percent) say opioid addiction is a serious problem in their community, and about half (49 percent) say they personally know someone who has struggled with opioid addiction. “What has been widely recognized is the serious economic problems facing rural communities today. What has not is that drug/opioid abuse in rural communities is now viewed with the same high level of concern as economic threats,” said Robert J. Blendon, co-director of the survey and the Richard L. Menschel Professor of Health Policy and Political Analysis at Harvard T.H. Chan School of Public Health.

On economic issues, rural Americans largely hold negative views of their local economy, but nearly one-third have seen economic progress in recent years. A majority of rural Americans (55 percent) rate their local economy as only fair or poor, while over the past five years, 31% say their local economy has gotten better, and 21 percent say it has gotten worse.

Rural Americans are divided over whether they expect the major problems facing their communities will be solved in the near future, and a majority believe outside help will be necessary to solve these problems. About half of rural Americans (51 percent) say they are confident that major problems facing their local community will be solved in the next five years, and 58 percent believe their community needs outside help to solve its major problems. Among those who say their community needs outside help, about six in ten rural Americans (61 percent) think the government will play the greatest role in solving major problems facing their local community.

In addition, many rural Americans are optimistic about the future. A majority of rural parents (55 percent) think their children will be better off financially than themselves when their children become their age. “There is no single vision of life in small-town America, just as there is no one-size-fits-all solution to improving health,” said Richard Besser, president and CEO of the Robert Wood Johnson Foundation. “But we see in this diversity a common thread — an understanding that health and wellbeing means many things: better access to health care, good job opportunities, and quality education for all.”

Key Findings

Many rural Americans are optimistic about future jobs

Many rural Americans are optimistic about future job opportunities, but they recognize new training and skills may be important for the future rural workforce. Looking ahead five years, 39 percent of rural Americans believe the number of good jobs in their local economy will increase, while 47% believe they will stay the same.

About one-third of rural Americans (34 percent) say it will be important for them to get training or develop new skills in order to keep their job or find a better job in their local community in the next five years, including 25 percent of all rural adults who say they will need computer and technical skills and 24% who say they will need a first or more advanced educational degree or certificate.

Education, job growth, and health care will improve rural economies

When it comes to improving their local economy, a majority of rural Americans think the following approaches would be very helpful: creating better long-term job opportunities (64 percent), improving the quality of local public schools (61 percent), improving access to health care (55 percent), and improving access to advanced job training or skills development (51 percent). (See table below.)

Rural Americans’ Views on Approaches to Improving the Local Rural Economy

Q44. Recently, a number of leadership groups have recommended different approaches for improving the economy of communities like yours. For each of the following, please tell me how helpful you think this approach would be for improving the economy of your local community…[insert item]. Do you think this would be very helpful, somewhat helpful, not too helpful, or not at all helpful?

Percent saying “very helpful”

1. Creating better long-term job opportunities

64%

2. Improving the quality of local public schools

61%

3. Improving access to health care

55%

4. Improving access to advanced job training or skills development

51%

5. Improving local infrastructure like roads, bridges, and public buildings

48%

6. Improving the use of advanced technology in local industry and farming

There are sizable gaps between how minorities and non-minorities believe people are treated in rural communities

Despite low recognition of discrimination against minority groups in their local community by all rural Americans, rural adults belonging to several minority groups see much higher rates of discrimination against members of their group. For example, only 21 percent of all rural Americans say that generally speaking, they think Latinos are discriminated against in their local community, yet 44 percent of Latinos living in rural areas say they think Latinos are discriminated against in their local community. A majority of Latinos (56 percent) also say they think recent immigrants are discriminated against in their local community, compared to 29 percent of all rural Americans who share this view.

The poll in this study is part of an on-going series of surveys developed by researchers at the Harvard Opinion Research Program (HORP) at Harvard T.H. Chan School of Public Health in partnership with the Robert Wood Johnson Foundation and National Public Radio. The research team consists of the following members at each institution.

Harvard T.H. Chan School of Public Health: Robert J. Blendon, Professor of Health Policy and Political Analysis and Executive Director of HORP; John M. Benson, Senior Research Scientist and Managing Director of HORP; Mary T. Gorski Findling, Research Associate; Logan S. Casey, Research Associate in Public Opinion; Justin M. Sayde, Administrative and Research Manager.

Robert Wood Johnson Foundation: Carolyn Miller, Senior Program Officer, Research and Evaluation; and Jordan Reese, Director of Media Relations.

Interviews were conducted by SSRS of Glen Mills (PA) via telephone (including both landline and cell phone) using random-digit dialing, June 6 – August 4, 2018, among a nationally representative probability-based sample of 1,300 adults age 18 or older living in the rural United States. Interviews were conducted in English and Spanish. The margin of error for total respondents is ±3.6 percentage points at the 95% confidence level. The sample of Rural Americans is defined in this survey as adults living in areas that are not part of a Metropolitan Statistical Area (MSA). This is the definition used in the 2016 National Exit Poll.

Possible sources of non-sampling error include non-response bias, as well as question wording and ordering effects. Non-response in telephone surveys produces some known biases in survey-derived estimates because participation tends to vary for different subgroups of the population. To compensate for these known biases and for variations in probability of selection within and across households, sample data are weighted by cell phone/landline use and demographics (sex, age, education, and Census region) to reflect the true population. Other techniques, including random-digit dialing, replicate subsamples, and systematic respondent selection within households, are used to ensure that the sample is representative.

WASHINGTON, Oct. 4, 2018 – A new interactive data tool launched by the United States Department of Agriculture and NORC at the University of Chicago shows for the first time an in-depth, county-by-county, look at the impact of the opioid epidemic across the entire country. The tool is intended to help leaders build grassroots strategies to better address the needs in their communities.

The opioid misuse Community Assessment Tool enables users to overlay substance misuse data against socioeconomic, census and other public information. This data will help leaders, researchers and policymakers assess what actions will be most effective in addressing the opioid crisis at the local level.

USDA’s launch of the Community Assessment Tool closely follows President Trump’s declaration of October as National Substance Abuse Prevention Month. Approximately 72,000 Americans died from drug overdoses in 2017; 49,000 of those deaths involved an opioid. Many of these deaths have been fueled by the misuse of prescription pain medications. The severity of the current opioid misuse crisis requires immediate action.

Rural Development partnered with the Walsh Center for Rural Health Analysis at NORC at the University of Chicago to create the Community Assessment Tool. NORC at the University of Chicago is a non-partisan research institution that delivers reliable data and rigorous analysis to guide critical programmatic, business and policy decisions. Today, government, corporate and nonprofit organizations around the world partner with NORC to transform increasingly complex information into useful knowledge. The Walsh Center focuses on a wide array of issues affecting rural providers and residents, including health care quality and public health systems.

In April 2017, President Trump established the Interagency Task Force on Agriculture and Rural Prosperity to identify legislative, regulatory and policy changes that could promote agriculture and prosperity in rural communities. In January 2018, Secretary Perdue presented the Task Force’s findings to President Trump. These findings included 31 recommendations to align the federal government with state, local and tribal governments to take advantage of opportunities that exist in rural America. Increasing investments in rural infrastructure is a key recommendation of the task force.

BIRMINGHAM ─ ProAssurance Corporation has announced an exclusive affiliation with Sure Med Compliance® (SMC) to promote the use of SMC’s Care Continuity Program® (CCP) in an effort to help combat the opioid epidemic in the United States.

ProAssurance-insured physicians will be eligible for discounted access to Sure Med’s Care Continuity Program

The CCP helps physicians and other health care providers develop and maintain responsible prescribing practices for opioids and other scheduled medications by equipping them with tools to verify patients suitable for opioid therapy, identify with significant risk factors, and closely monitor the effects of treatment over time.

“As an industry leader, we are acutely aware of the devastating effects of the opioid epidemic in this country. We are concerned about the epidemic’s professional liability implications for physicians and other healthcare providers, as well as its broader effects on the healthcare system in general. We are proud to affiliate with Sure Med Compliance to offer our insureds exclusive discounted access to this cutting-edge approach to patient safety and effective treatment, ” said Howard H. Friedman, president of ProAssurance’s Healthcare Professional Liability Group.

John Bowman, Sure Med Compliance’s Chief Executive Officer, emphasized the importance of the newly formed affiliation.

“Our Care Continuity Program provides a proven path toward optimal outcomes for patients whose treatment requires the use of opioids and other potentially addictive drugs,” Bowman said. “In turn, CCP helps physicians avoid potential liability issues, which has always been a focus of ProAssurance and why we are so excited about this affiliation. We are confident their national footprint will help Sure Med Compliance reach more physicians and assist more patients than ever before.”

Through this affiliation, ProAssurance insureds who meet certain eligibility requirements will have access to an exclusive 30-day free trial of the CCP. ProAssurance insureds who elect to continue using the Care Continuity Program will receive exclusive discounted rates. ProAssurance insureds may contact Sure Med Compliance to determine eligibility and initiate a 30-day free trial by visiting www.suremedcompliance.com/proassurance or calling (866) 517-2771.

“As a practicing pain management specialist, I have experienced firsthand the challenges physicians face in deciding to prescribe controlled substances. Using the Sure Med Compliance CCP in my practice has helped me ensure proper documentation and address potential issues before they occur,” said Sure Med Compliance’s Medical Director David Herrick, M.D., of Montgomery. Dr. Herrick is a past president of the Medical Association of the State of Alabama and a former member of the Alabama Board of Medical Examiners.

“Our commitment to provide our insureds with exclusive discounted access to the Sure Med Compliance CCP underscores ProAssurance’s commitment to ensure physicians and other health care providers are equipped with the risk management tools and services necessary to deal with the ever-changing realities of their chosen profession,” Dr. Whiteside said. “All ProAssurance insureds who regularly prescribe opioids, especially those who prescribe for chronic pain, are encouraged to engage Sure Med Compliance to learn more about how their Care Continuity Program can help them develop and maintain safe and responsible prescribing practices, which should lead to better outcomes for their patients.”

Will clinicians become more careful in prescribing opioids if they are made of aware of the risks of these drugs first-hand? That was one of the core questions researchers set out to explore in a new study published in the August 2018 issue of Science. In doing so, they found that many clinicians do not learn of the deaths of those patients who overdose as they just disappear from their practice, outcomes unknown.

This disconnect from the personal experience of losing a patient due to fatal overdose, related to a prescription for opioids to relieve pain, makes the problem of the nation’s opioid crisis seem remote – statistics happening elsewhere. While the epidemic continues to exert its outsized impact, opioid prescription-writing levels have not responded with adequate risk-benefit analysis by prescribers tasked with caring for patients with complaints around pain.

“Clinicians may never know a patient they prescribed opioids to suffered a fatal overdose,” explained lead author Jason Doctor. “What we wanted to evaluate is whether closing that information gap will make them more judicious prescribers.” Doctor is the Director of Health Informatics at the USC Schaeffer Center for Health Policy & Economics and Associate Professor at the Price School of Public Policy.

The study leverages behavioral insights and psychology to give prescribers personal experience with the risk associated with opioids and finds that when a clinician learns one of their patients had suffered a fatal overdose they reduced the number of opioids prescribed by almost 10 percent in the following three months.

Doctor and his colleagues conducted a randomized trial between July 2015 and June 2016 of 861 clinicians who had prescribed to 170 patients who subsequently suffered a fatal overdose involving prescription opioids. Half the clinicians, who all practiced in San Diego County, were randomly selected to receive a letter from the county medical examiner notifying them that a patient they had prescribed opioids to in the past twelve months had a fatal overdose. The letter, which was supportive in tone, also provided information from the Centers for Disease Control and Prevention on safe prescribing guidelines, nudging clinicians toward better prescribing habits.

In the three months after receiving the letter, prescribing decreased by 9.7 percent compared to the control group who didn’t receive a letter. Furthermore, clinicians who received the letter were 7 percent less likely to start a new patient on opioids and less likely to prescribe higher doses.

The results are particularly exciting given that numerous, more traditional state regulations which often involve mandated limits on opioids have not been shown to have much impact. The authors point to numerous reasons why this study showed more promising results including its simplicity, that the letters still allows clinicians to decide when they will prescribe opioid analgesics and that it provides an important missing piece of clinical information to them.

This intervention is easily scalable nationwide as existing state and national resources already track the information necessary around overdose deaths associated with prescription and illicit drugs.

“Interventions that use behavioral insights to nudge clinicians to correct course are powerful, low-cost tools because they maintain the autonomy of the physician to ultimately decide the best course of care for their patient,” said Doctor. “In this case, we know opioids, though beneficial to some patients with certain conditions, come with high risks that the doctor may not fully grasp when observing patients in the clinic. Providing information about the harm that would otherwise go unseen by them gives physicians a clearer picture.”

###

Co-authors include Andy Nguyen, Roneet Lev, Jonathan Lucas, Tara Knight, Henu Zhao, and Michael Menchine. Funding for the study was provided by the California Health Care Foundation and the National Institute on Aging at the National Institutes of Health (R21-AG057395-01).

The Leonard D. Schaeffer Center for Health Policy & Economics, one of the nation’s leading health policy centers, aims to measurably improve value in health through evidence-based policy solutions, research and educational excellence, and private and public sector engagement. The Center is a unique collaboration between the USC School of Pharmacy and the Sol Price School of Public Policy at the University of Southern California (USC).

Study results show revised recommendations resulted in about 17 fewer pills being dispensed per patient for four major operations.

CHICAGO – To curb the use of opioids after major elective operations and prevent these pain relievers from falling into the wrong hands, surgeons at the University of Michigan developed prescribing recommendations based on published medical evidence for one operation, gallbladder removal, and then discovered a spillover effect that led them to prescribe roughly 10,000 fewer pills for other major operations, according to study results appearing as an “article in press” on the website of the Journal of the American College of Surgeons ahead of print.

“We changed how many opioids we dispense or prescribe to patients after laparoscopic cholecystectomy, which is performed for gallbladder removal,” said lead study author Michael Englesbe, MD, FACS, a transplant surgeon in the department of surgery, University of Michigan Health System, Ann Arbor. “As an unintended spillover consequence, the change had a significant impact on how we prescribe for other procedures.”

The study noted that surgeons have been known to overprescribe opioids after operations, resulting in leftover pills that can sometimes be diverted for illegal use. Dr. Englesbe and coauthors set out to determine if prescribing guidelines for one specific operation would have an impact on reducing opioids prescribed for other surgical procedures.

In a previous study, * Dr. Englesbe and coauthors described their recommendations for opioids after minimally invasive gallbladder removal: 15 tablets of hydrocodone/ acetaminophen 5/325 mg or 10 tablets of oxycodone 5 mg; along with encouraging the use of non-opioid pain medications such as acetaminophen or ibuprofen. They found that after implementing the recommendation, opioid prescriptions also declined significantly for four other types of major operations—thyroidectomy or parathyroidectomy (removal of all or part of the thyroid gland), and laparoscopic, or minimally invasive, appendectomy (surgical removal of the appendix), inguinal hernia repair, and sleeve gastrectomy (a weight-loss operation in which a portion of the stomach is removed).

The study involved reviews of 1,158 patient charts, 558 who had operations before the opioid recommendations were implemented and 600 over 10 months afterward to compare surgeons’ prescribing behavior. For sleeve gastrectomy, the most extensive operation, the average prescription after surgery went from around 89 pills before the recommendations to around 58 afterward, about a 35 percent reduction. The reductions for the other operations were more significant: about 43 percent for hernia repair (37 pills before to 21 after); and 50 percent or more for appendectomy (35 to 17 pills) and thyroidectomy/parathyroidectomy (16 to 8 pills). The prescriptions were measured in oral morphine equivalents, with 100 OMEs equal to about 20 pills of hydrocodone/acetaminophen 5/325 mg.

Dr. Englesbe explained why the researchers chose these four operations: “These procedures are not usually performed to treat pain, so there is an expectation that patients will have the procedure and essentially recover relatively quickly; and they are relatively straightforward elective operations that are commonly done across Michigan and throughout the United States.”

Despite the reduction in prescribing, patients requested refills after only minimally invasive appendectomy. Prescriptions for non-opioid analgesics also increased significantly for two procedures. For the four procedures across the entire study population, the revised recommendations resulted in roughly 10,000 fewer pills entering the community. On average, that equals about 17 fewer pills per patient.

“These findings are relevant to any surgeon,” Dr. Englesbe said. “Every surgeon, no matter what specialty or procedure they do, dentists included, needs to be thoughtful about how they prescribe opioids and be realistic that overprescribing can really have some devastating complications.”

Since the original recommendations for opioids after gallbladder removal, the Michigan Surgical Quality Collaborative and Opioid Prescribing Engagement Network have developed recommendations for 17 other procedures, including three types of hysterectomy, breast biopsy, and mastectomy. The recommendations are reviewed quarterly and updated as needed, Dr. Englesbe said, and will soon include some dental procedures. The recommendations are available at https://opioidprescribing.info.

“Some patients do not do well with opioids, and we as providers need to be very thoughtful while we give the best pain care possible but at the same time also make sure it’s the safest pain care,” Dr. Englesbe said.

Dr. Englesbe’s coauthors are Ryan Howard, MD, and Jay Lee, MD, of the department of surgery, Michigan Medicine, Ann Arbor; Mitchell Alameddine, BS, and Michael Klueh, BS, of the University of Michigan Medical School, Ann Arbor; Chad Brummett, MD, of the department of anesthesia, University of Michigan Health System; and Jennifer Waljee, MD, MS, MPH, FACS, of the section of plastic surgery, department of surgery, University of Michigan Health System.

“FACS” designates that a surgeon is a Fellow of the American College of Surgeons.

In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. In this article, I discuss the consequences physicians and other medical professionals potentially face as a result of a “pill mill” investigation.

CRIMINAL PROSECUTION

A litany of criminal charges can be heaped on medical professionals at the conclusion of a “pill mill” investigation. Exactly what charges the government pursues will obviously depend on the facts and circumstances of each particular case. One charge that will inevitably be included in every “pill mill” indictment is an alleged violation of the Controlled Substances Act (“CSA”). The CSA governs the distribution and dispensing of various listed drugs, including narcotics, that are prescribed by physicians and other licensed medical providers. To issue a controlled substance, a physician must be licensed to practice by a state authority and must have a DEA registration number.

Under the CSA, controlled substances are placed into one of five “schedules” based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and their likelihood of causing dependence when abused. Most opioids are Schedule II drugs because they have acceptable medical uses and but a high potential for abuse.

To be convicted under the CSA, the government must prove that (1) the defendant physician knowingly and intentionally distributed or dispensed a controlled substance, and (2) did so “for no legitimate medical purpose and outside the usual course of professional practice.” Determining whether a physician has illegally prescribed drugs under this standard is never simple and will necessarily involve a “battle of the experts.”

A criminal conviction for violating the CSA may result in a vast array of prison sentences under the federal Sentencing Guidelines, a set of advisory sentencing rules that establish a uniform policy for individuals convicted of felony crimes in federal court. The exact range may vary significantly from case-to-case, depending primarily on the type and quantity of controlled substances involved. And these ranges can be staggeringly severe. In a recent “pill mill” case in Mobile, Ala., the physicians each faced a guidelines range of imprisonment of 30 to 240 years, although the court sentenced them well below that range (20 and 21 years, respectively) – as it had the discretion to do. In addition to applicable guidelines ranges in each case, the CSA provides for statutorily “enhanced” sentences in certain circumstances. For instance, if the government proves that a patient’s death resulted from the distribution of a Schedule II controlled substance, the convicted physician will face a sentence of no less than 20 years and up to life in prison.

SEIZURE AND FORFEITURE

In almost every “pill mill” case, the government will attempt to seize (take possession of) and forfeit (take ownership of) bank accounts, business assets, and personal assets of the targeted medical professional based on a theory that they are “proceeds” of the alleged “pill mill” operation or somehow “facilitated” the purported criminal enterprise. For example, following the physicians’ convictions in the case mentioned above, the government forfeited their bank accounts, investment and retirement accounts, college fund accounts, houses, beach-fount condominiums, and 20-plus luxury automobiles.

CIVIL LIABILITY

On top of criminal prosecution, a “pill mill” investigation could result in a civil lawsuit by the government against the targeted physician or medical professional, to the extent they have billed a federal health care program. For instance, the government might bring a direct suit under the False Claims Act (“FCA”), alleging that the physician made false diagnoses, prescribed drugs for non-covered indications, or prescribed excessive or “medically unnecessary” drugs for Medicare or Medicaid patients. Likewise, the government may join in a “qui tam” suit, which is initiated by a “whistleblower” – such as a current or former employee of the practice – claiming the targeted physician or practice has violated the FCA and other laws.

ADMINISTRATIVE PROCEEDINGS

In addition to facing criminal prosecution, the loss of asserts, and civil liability, physicians investigated or charged in a “pill mill” case can be subject to a number of administrative sanctions. The DEA, in particular, has a range of administrative actions it can take, such as: issuing a letter of admonition to the registrant providing notice of a violation of the applicable law/regulations; requiring the registrant to enter into a memorandum of understanding agreeing to take certain corrective steps to stave off revocation of the registration; or, for the most serious alleged violations, pursuing a show cause order to appear before an administrative law judge, during which the DEA will advocate for revocation of the registration.

Like the DEA, state professional boards (such as medical and pharmacy boards) have disciplinary authority and can sanction practitioners for professional violations, such prohibiting a physician from prescribing specific schedules of drugs, suspending a physician’s medical and/or dispensing license, or revoking the license.

Further, the Centers for Medicare & Medicaid Services (“CMS”) may limit, suspend, or revoke a provider’s Medicare billing privileges for, among other things, noncompliance with Medicare enrolment requirements, a felony conviction related to controlled substances, or a pattern of improper prescribing practices. Likewise, state Medicaid agencies can impose various administrative sanctions against providers, including outright exclusion from the program.

CONCLUSION

The consequences physicians and other medical professionals face as a result of a “pill mill” investigation are varied and potentially severe. Given that, pain management practitioners should be acutely aware of any signs that they are under investigation, including, among other things, receiving a government subpoena or civil investigative demand or learning that the practice’s employees or patients have been interviewed by investigating agents. Upon receiving the slightest hint of an investigation, practitioners should act quickly in obtaining legal counsel to conduct an internal investigation, determine the practice’s potential exposure, and intervene on the practice’s behalf in the hopes of warding off further government scrutiny.

For more information on these issues, please contact Burr & Forman’s Health Care team. Burr & Forman is an official partner with the Medical Association.

MONTGOMERY ─ Earlier this week, the Governor’s Opioid Overdose and Addiction Council met to discuss reports from various stakeholders and committees, but there was also a special guest speaker. Daniel Blaney-Koen, senior legislative attorney from the American Medical Association, joined the task force to discuss what the AMA is doing nationally with policy interventions to try and reverse the opioid epidemic as well as its partnership with the Medical Association with the development and promotion of a toolkit to provide more educational material to Alabama’s physicians.

According to Blaney-Koen, opioid prescriptions are decreasing nationwide, and Alabama has beaten the national average in reducing the number of opioids prescribed.

“We want to emphasize solutions,” Blaney-Koen said. “I’d rather emphasize solutions that can change the course of this epidemic. We all want this epidemic to end, and there is hope for optimism that it will. The unmet needs for treatment are what will sustain this epidemic, so evidence-based care and treatment is where we need to put our focus.”